A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Bactroban Side Effects, and Drug Interactions - Mupirocin
Bactroban Side Effects, and Drug Interactions - Mupirocin
SIDE EFFECTS
Clinical Trials
In clinical trials, 210 domestic and 2,130 foreign adult subjects/patients
received Bactroban Nasal ointment. Less than 1% of domestic or foreign
subjects and patients in clinical trials were withdrawn due to adverse events.
The most frequently reported adverse events in foreign clinical trials were
as follows: rhinitis (1.0%), taste perversion (0.8%), pharyngitis (0.5%).
In domestic clinical trials, 17% (36/210) of adults treated with Bactroban
Nasal ointment reported adverse events thought to be at least possibly drug-related.
The incidence of adverse events that were reported in at least 1% of adults
enrolled in domestic clinical trials were as follows:
ADVERSE EVENTS (>=1% INCIDENCE)-
ADULTS IN U.S. TRIALS
|
|
% of Subjects/Patients Experiencing Event
Bactroban Nasal 2%
(n=210) |
|
Headache
|
9% |
|
Rhinitis
|
6% |
|
Respiratory disorder,
including upper respiratory
tract congestion
|
5% |
|
Pharyngitis
|
4% |
|
Taste perversion
|
3% |
|
Burning/Stinging
|
2% |
|
Cough
|
2% |
|
Pruritus
|
1% |
The following events thought possibly drug-related were reported in less than
1% of adults enrolled in domestic clinical trials: blepharitis, diarrhea, dry
mouth, ear pain, epistaxis, nausea and rash.
All adequate and well-controlled clinical trials have been performed using
Bactroban Nasal ointment, 2% in one arm and the vehicle ointment in the
other arm of the study. No adequate and well-controlled safety data are available
from direct, head-to-head comparative studies of this product and other products
for this indication.
DRUG INTERACTIONS
The effect of the concurrent application of intranasal mupirocin calcium and
other intranasal products has not been studied. Until further information is
known, mupirocin calcium ointment, 2% should not be applied concurrently with
any other intranasal products.
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